Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- The main outcome measure is the number of exacerbations over the 12 months of follow-up.
研究概览
简要总结
The main objective of this trial is to compare the exacerbation number over 12 months of follow-up between a group of patients with COPD treated according to standardized management (azithromycin prescribed in the event of severe sputum according to the CASA-Q score , standardized comparator arm) and a similar group in which azithromycin is prescribed based on mucus rheology (experimental arm) or CASA-Q.
详细描述
The secondary objectives are to compare between the 2 arms:
- exacerbation number according to their severity (observed throughout the duration of the study);
- the evolution of the symptoms, the rheology of the sputum, and the pulmonary function (measurements repeated every three months);
- medication consumption and adverse events (monitored throughout the duration of the study);
- patient trajectories during follow-up;
- the overall clinical improvement at the end of the study and the evolution of the quality of life (measurements repeated every 3 months);
- the change in biomarkers of interest (baseline versus end of study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
CASA-Q scoring is performed by the patient and then sealed away from investigator-view. Similarly, mucus rheology results are blinded. The patient does not know what arm he/she is in, as so does not know exactly why the prescription was made or not.
Similarly, investigators/outcome assessors are blinded to both CASA-Q scores and sputum rheology. The prescription strategy is determined according to an algorithm, and investigators/outcome assessors do not know what arm the patient is in nor exactly why a prescription was made or not.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjets between 40 - 85 years (included)
- •Written and signed informed consent form
- •Subjects must be able to attend all planned visits and comply with all test procedures
- •Beneficiary of or affiliated with the French social security system
- •Man or woman with chronic obstructive pulmonary disease for at least 1 year defined according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and validated by the clinical investigator
- •Optimal treatment according to GOLD class severity C or D recommendations
- •>=3 exacerbation (regardless of severity: mild-moderate-severe) or ≥ 1 severe exacerbations (requiring hospitalization) in the past 12 months
- •Spontaneous or induced sputum production
- •Electrocardiogram: corrected distance between Q and T waves (QTC) <450 ms in men, QTC <470 ms in women
- •Normal audiogram for age or absence of contraindication to azithromycin for long course according to Oto-Rhino-Laryngological specialist opinion
排除标准
- •Pregnancy or breastfeeding
- •Patients who are prisoners or under other forms of judicial protection
- •Patients under any form of guardianship
- •Participation in another interventional protocol, (current or during the month preceding inclusion)
- •Received azithromycin in the past 3 months
- •Patient whose primary diagnosis is bronchial dilation based on CT scan documentation
- •Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used
- •Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)
- •Other respiratory diseases or associated lung infections
- •Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion)
- •Renal impairment with creatinine clearance < 40 mL/min
- •Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation
- •Patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary disease) due to the presence of lactose in the specialty Zithromax.
研究组 & 干预措施
Azithromycin according to symptoms
Patients randomized to this arm will be prescribed azithromycin in function of their symptoms.
干预措施: Azithropycin according to symptoms (Drug)
Azithromycin according to rheology
Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.
干预措施: Azithromycin according to rheology or symptoms (Drug)
结局指标
主要结局
The main outcome measure is the number of exacerbations over the 12 months of follow-up.
时间窗: 12 months
An exacerbation is defined according to French recommendations as an "acute event characterized by worsening of respiratory symptoms (notably cough, sputum and dyspnea) beyond \[normal\] daily variation and leading to a modification of treatment: either a simple increase in bronchodilators (in this case, a duration greater than 24 hours is required to define an exacerbation) or the addition of another treatment (antibiotic therapy and / or oral corticosteroid therapy)."
次要结局
- COPD Assessment Test (CAT)(12 months)
- Sino Nasal Outcome Test 22(12 months)
- Rheology: the viscous module (G '')(12 months)
- Rheology: The ratio G '' / G '(12 months)
- Rheology: the critical constraint (tau-C).(12 months)
- Spirometry: forced expiratory volume in 1 minute (FEV1)(12 months)
- The number of mild exacerbations throughout follow-up(12 months)
- The number of moderate exacerbations throughout follow-up(12 months)
- The number of severe exacerbations throughout follow-up(12 months)
- Serum Club cell secretory protein(12 months)
- Visual analogue scale for sputum production(12 months)
- Cough and sputum assessment questionnaire (CASA-Q)(12 months)
- Visual analogue scale for coughing(12 months)
- Rheology: modulus of elasticity of mucus (G ')(12 months)
- Sputum bacteriology(12 months)
- Visual analogue scale for dyspnea(12 months)
- Spirometry: forced vital capacity (FVC)(12 months)
- Spirometry: FEV1/FVC(12 months)
- Plethysmography for lung volumes: residual volume (RV)(12 months)
- Plethysmography for lung volumes: functional residual capacity (FRC)(12 months)
- Plethysmography for lung volumes: total lung capacity (TLC)(12 months)
- Plethysmography for lung volumes: RV/TLC(12 months)
- Drug consumption throughout the study.(12 months)
- The number of adverse events will be recorded throughout the study.(12 months)
- Episodes of exacerbation throughout the study(12 months)
- Episodes of hospitalization throughout the study(12 months)
- Clinical improvement(12 months)
- Medical outcomes study 36-Item Short Form Survey (SF-36)(12 months)
- EQ-5D-5L(12 months)
- St-George's Respiratory Questionnaire(12 months)
- Blood cell differential: neutrophil levels(12 months)
- Blood cell differential: eosinophil levels(12 months)